ImportRefusal LogoImportRefusal

LABORATORIOS MK FABRICADO POR TE

⚠️ High Risk

FEI: 3031229153 • Valle Del Cauca • COLOMBIA

FEI

FEI Number

3031229153

📍

Location

Valle Del Cauca

🇨🇴

Country

COLOMBIA
🏢

Address

Cra 3 26-361 Jamundi, , Valle Del Cauca, , Colombia

High Risk

FDA Import Risk Assessment

56.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
3/7/2025
Latest Refusal
3/7/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
78.6×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
3/7/2025
62GCH41IBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS MK FABRICADO POR TE's FDA import refusal history?

LABORATORIOS MK FABRICADO POR TE (FEI: 3031229153) has 1 FDA import refusal record(s) in our database, spanning from 3/7/2025 to 3/7/2025.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. LABORATORIOS MK FABRICADO POR TE's FEI number is 3031229153.

What types of violations has LABORATORIOS MK FABRICADO POR TE received?

LABORATORIOS MK FABRICADO POR TE has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about LABORATORIOS MK FABRICADO POR TE come from?

All FDA import refusal data for LABORATORIOS MK FABRICADO POR TE is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.